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The Efficacy and Safety of Gynomax® XL Vaginal Ovule in the Treatment of Common Vaginal Infections: A Single-Arm Clinical Trial, Gyno-Türk
Received: 27 Aug 2021 | Accepted: 04 Jan 2022 | Available online: 18 Jan 2022Erol TAVMERGENa, Ferruh ACETa, Cüneyt Eftal TANERb, Fatih DURMUŞOĞLUc, Yaprak ÜSTÜNd, Berna DİLBAZd, Fatma Feriha ÇİLLİe
aDepartment of Obstetrics and Gynecology, Ege University Faculty of Medicine, İzmir, TURKEY
bDepartment of Obstetrics and Gynecology, İzmir University of Health Sciences Tepecik Training and Research Hospital, İzmir, TURKEY
cClinic of Obstetrics and Gynecology, Hisar Hospital, İstanbul, TURKEY
dDepartment of Obstetrics and Gynecology, University of Health Sciences Etlik Zübeyde Hanım Training and Research Hospital, Ankara, TURKEY
eDepartment of Microbiology, Ege University Faculty of Medicine, İzmir, TURKEY
JCOG. 2021;31(4):120-8
DOI: 10.5336/jcog.2021-85924
Article Language: EN
Copyright Ⓒ 2024 by Türkiye Klinikleri. This is an open access article under the CC BY-NC-ND license (
http://creativecommons.org/licenses/by-nc-nd/4.0/)
ABSTRACT
Objective: The objective of this study was to evaluate the efficacy, safety, and tolerability of Gynomax® XL vaginal ovule in the treatment of bacterial vaginosis (BV), candidal vulvovaginitis (CVV), trichomonal vaginitis (TV), and mixed vaginal infections (MVI). Material and Methods: A total of 98 women diagnosed clinically with BV, CVV, TV, or MVI have completed this study. Patients were given Gynomax® XL for 3 consecutive days, and approximately 10 (+/-5) days after the treatment, a follow-up visit was conducted. In addition to the clinical examinations, vaginal swab samples were collected in both visits for microbiological tests. Results: Based on the clinical diagnosis of the investigators, most of the patients had MVIs (54.1%), followed by BV (24.5%) and CVV (20.4%) at the baseline visit. One (1.0%) patient was diagnosed as having TV. According to the microbiologic examination results, 44 (44.9%) patients had BV, 20 (20.4%) had CVV, and 13 (13.3%) had MVIs. According to the clinical findings, overall complete recovery (CR) was observed in 76.5% of the patients and according to the microbiologic findings, overall CR was observed in 85.7% of the patients. Microbiologic results evaluated by each diagnostic criterion showed that CR was detected in 93.2%, 85.0%, and 61.5% of the patients with BV, CVV, and MVIs, respectively. There were no serious or non-serious adverse events leading to patient withdrawal or treatment discontinuation during this study. Conclusion: Gynomax® XL vaginal ovules administered once daily for three consecutive days provide effective and safe treatment in patients with BV, CVV, and MVIs.
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